Category Human Rights

The TPP’s Reckless Proposals For Damages Will Have Negative Impact On Future Reform Of IPR Regimes

James Love writes: This week negotiators from a dozen countries are meeting to finalize the rules for the Trans Pacific Partnership (TPP) trade agreement. When or if concluded, this massive regional trade agreement will set new standards for the grant of property rights in knowledge, and the enforcement of those rights.

The TPP chapter on intellectual property covers all intellectual property types included in Part II of the WTO's TRIPS agreement, plus some others, including not only patents, copyrights and trademarks, but also "undisclosed information", test data for the registration of drugs, industrial designs, layout-designs of integrated circuits. The rules in the TPP are intended by the United States to become global norms, effectively replacing TRIPS.

While there are plenty of issues in the TPP IP Chapter, this note only addresses one set of issues -- those relating to the remedies for the infringement of intellectual property rights. The remedies include such topics as injunctions, damages, and the seizure or destruction of infringing goods.

Decision Time On Biologics Exclusivity: Eight Years Is No Compromise

Burcu Kilic and Courtney Pine write: As the Trans-Pacific Partnership (TPP) negotiations approach their endgame, biologics exclusivity is still considered “one of the most difficult outstanding issues in the negotiation.”[2] Pharmaceutical companies seek longer data and marketing exclusivities to further delay market entry of cost-saving biosimilar drugs. Data exclusivity prevents follow-on pharmaceutical developers from relying on originators’ test data submitted for marketing approval while seeking such approval for its own product. The World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires some protection against unfair competition for this sort of data, but it does not require countries to adopt rules conveying exclusive rights over it in the same way as it does regarding patents.[3] Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).[4] The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law, The Patient Protection and Affordable Care Act. A robust debate over what would be an appropriate exclusivity period, if any, was overshadowed by other controversial aspects of the bill commonly referred to as Obamacare.

EU Commissioner Signals Support For LDC Request To Waive IP Rights Enforcement On Pharma

European Trade Commissioner Cecilia Malmström said in a recent speech that providing she has the backing of the College of Commissioners, the Council and the European Parliament, she would like to answer positively to the request by least developed countries (LDCs) to extend a particular exemption to enforce intellectual property rights on medical products as long as they remain an LDC.

Learning From Ebola

In 1976, Yambuku village school headmaster Mabalo Lokela felt sick when he returned from a trip to northern Zaire near the Central African Republic border. He had a high fever, diarrhea, and bleeding. Because he was initially believed to have malaria, Lokela was given quinine, but his symptoms got worse and he soon died. Shortly afterwards, those who had been in contact with Lokela also died. ... Almost four decades later, there is still no cure for Ebola, despite the fact that drug development on average takes about a third of this time frame, write William Fisher and Quentin Palfrey.